MAIA Biotechnology, Inc. (MAIA), a clinical-stage immuno-oncology company, announced that the U.S. Food and Drug Administration, or FDA, has cleared an amendment to MAIA's IND to commence U.S enrollment for the expansion of the Phase 2 THIO-101 trial of its lead investigational candidate, Ateganosine, for the treatment of lung cancer.
FDA's clearance of MAIA's updated IND is supported by updated manufacturing efficiencies, including new manufacturers and formulation and storage conditions for Ateganosine.
Ateganosine, also known as 6-thio-dG, is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer. Notably, FDA granted Fast Track designation in July 2025 for ateganosine to treat NSCLC.
THIO-101 is a multicentre, open-label, dose-finding Phase 2 clinical trial designed to evaluate Ateganosine's anti-tumour activity when followed by PD-(L)1 inhibition.
The trial design has two primary objectives: to evaluate the safety and tolerability of Ateganosine administered as an anticancer compound and a priming immune activator, and to assess the clinical efficacy of Ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint.
The expanded phase 2 study will evaluate the overall response rate (ORR) among patients resistant to checkpoint inhibitor (CPI) therapy and/or chemotherapy.
Treatment with Ateganosine followed by cemiplimab (Libtayo) has shown an acceptable safety profile to date in a heavily pre-treated population, stated the firm.
The additional data from the THIO-101 phase 2 expansion study may further support a filing for FDA Accelerated Approval, the company stated.
On the other hand, MAIA is also enrolling patients in the phase 3 THIO-104 clinical trial, designed to evaluate overall survival with Ateganosine plus a CPI versus the investigator's choice of chemotherapy in a 1:1 randomisation of up to 300 third-line NSCLC patients. MAIA has traded between $0.87 and $3.19 over the last year. MAIA closed Wednesday's trading up 5.93% to $1.43. In the overnight market shares are trading up 5.26% to $1.50.
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